Kornimate/medical-research-clean huggingface dataset:
gait profile score in children with cerebral palsy (cp): influence of the cp type, treatment with botulinum injection and multilevel surgery

Conditions: Cerebral Palsy; Gait Disorders in Children

Summary: instrumented three dimensional gait analysis (3dga) permits to record spatial, temporal, kinetics, kinematics and electromyographic (emg) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (cp). nowadays, single-event multilevel surgery in subjects with cp cannot be performed without 3dga. however, interpretation of multiple and interdependent data remains complex for the clinician. to address this issue, gait statistical index have been developed to give a single measure of the quality of the gait pattern. among actual index, the gait profile score (gps), developed by baker et al (2009), measure the deviation of kinematics parameters from a controlled dataset. the gps can be divided in nine gait variable score (gvs), corresponding to major lower limb joints: the map (movement analysis profile). many studies have reported the interest of the gps to analysis gait of subjects with cp: good inter-session reliability, predictor of postoperative kinematic improvement, minimal clinical threshold calculated at 1.6°, significant relationship with clinical data (joint contractures), and sensibility to change after a single-event multilevel surgery.


Eligibility criteria:
inclusion criteria: * etiology of cerebral palsy * unilateral, bilateral, triplegic or quadriplegic forms of cerebral palsy. * 6 to 18 years old * gmfcs (gross motor function classification system) i to iii * instrumented gait analysis of the laboratory of st-etienne * absence of botulinum toxin injection or serial casting in the three months after a first instrumented gait analysis. exclusion criteria: * etiology others than cerebral palsy as defined classically (ex: ischemic infarcts in a child older than two years). * previous surgery in lower-limb.

Keywords: cerebral palsy gait profile score botulinum toxin injection multilevel surgery
directvision for urinary catheterization

Conditions: Urethral Diseases

Summary: the center for disease control and prevention (cdc) reports that one in four patients hospitalized in the united states is catheterized to void the bladder or monitor urinary output. in the male population, dr. singh, an urologist estimates that about 20% of catheterizations are difficult. driving a catheter blindly, guessing whether to push the catheter forward or manipulate it to get around a point of resistance leads to the risk of injury which increases the more the catheter is manipulated. additional adverse events include: urosepsis, uti and bladder perforation. the standard of care treatment for patients with difficult urinary catheterization (duc) is to proceed with a cystoscopic catheter placement or suprapubic tube placement. percuvision has the only foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals. moreover, it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure. in this study, the investigators plan on assessing the effectiveness and ease of use of the percuvision directvision® system device.

routine placement of transurethral catheters can be challenging in some situations, such as urethral strictures, severe phimosis and false passages. intravaginal retraction of the urethral meatus can complicate foley placement in postmenopausal females. in men, blind urethral procedures with mechanical or metal sounds without visual guidance or guidewire assistance are now discouraged due to the increased risk of urethral trauma and false passages. directvision is a new visually-guided catheterization device (vgcd) that uses a camera visual guide / microendoscope within a triple lumen flexible urinary catheter with an angled tip, essentially combining the functionality of a urinary catheter with a cystoscope. directvision uses fiber-optic bundle of 6,000 integrated fibers to provide illumination and transmit real-time video. procedures done via flexible cystoscopy or directvision are covered by insurance (including medicaid/medicare). in this prospective study, the investigators plan on assessing the effectiveness and ease of use of directvision - a direct visualization system for urinary catheterization.

Eligibility criteria:
inclusion criteria: * any patient over 18 years with a standard indication for difficult urinary catheterization exclusion criteria: * any patient younger than 18 years of age, pregnant patients
randomized trial of coronary angioplasty for de novo lesions in small vessels with drug eluting balloon.

Conditions: Coronary Disease

Summary: significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the des (drug eluting stent) era. recently has been developed drug eluting balloons (debs), which have been successfully tested in small series on in-stent restenosis, but few evidence is available in the context of small vessels disease. the current study has been designed to know, in one hand, the clinical efficacy of the drug elluting balloon in.pact falcon and, in other hand, the effectiveness, and the cost-effectiveness incremental analysis of debs (in.pact falcon vs. des ( resolute integrity) in patients with de novo lesions in small vessels.

recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting neointimal proliferation, and thus the limitation of restenosis, which has led to the conception and development of drug-coated balloon or "drug eluting balloons" (deb), releasing the antiproliferative drug at the time of expansion. initially they were applied in the treatment of in-stent restenosis. however, deb may represent a therapeutic alternative in other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary revascularization with stent implantation, as is the case of coronary lesions located in small vessels.

Eligibility criteria:
inclusion criteria: 1. older than 18, informed consent. 2. evidence of cad with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or \>50% by ct scan); affecting 3. vessels between 2,25 and 2,75 mm diameter and 4. the length of the coronary stenosis ≤25 mm 5. patient informed consent form signed. exclusion criteria: 1. lesion in coronary left main , 2. chronic total occlusions, 3. lesions at bifurcation, 4. severe calcified lesions, 5. lesions in aorto-coronary saphenous veins or arterial grafts, 6. acute myocardial infarction during 48 hours before the procedure, 7. severe renal dysfunction, 8. hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel, 9. allergy to contrast media, 10. life expectancy less than 1 year, 11. 1 year fu not guaranteed, 12. being participating in another study.

Keywords: angioplasty percutaneous transluminal coronary angioplasty drug elluting balloon coronary balloon dilatation
effects of paired associative nerve stimulation on spinal cord injury subjects

Conditions: Spinal Cord Injuries

Summary: this study is to investigate the effects of repetitive transcranial magnetic stimulation (rtms) combined with trans-spinal electrical stimulation (tses) intervention on cortical excitability, brain structure, motor ability of lower limb in individuals with incomplete spinal cord injury. twelve participants will be recruited in this study.

spinal cord injury (sci) impairs motor and sensory function and affects numerous body functions and daily activities. insufficient central nervous system plasticity can result in maladaptive changes that prevent full recovery. it's a challenge to guide this plasticity to optimize the functional outcome for individuals with sci. transcranial magnetic stimulation (tms) and trans-spinal electric stimulation (tses) may modulate cortical excitability, corticospinal output and spinal circuit. however, few studies investigated the effectiveness of paired nerve stimulation (pns) on neuroplasticity and functional outcome in persons with sci. therefore, this study aim to examine the effects of the combination of these two different non-invasive nerve stimulation with the cycling exercise on the motor cortex and corticospinal circuit excitability as well as functional recovery. present study clarifies the effects of five different settings of combined with tms and tses intervention and then undergo cycling exercise after pns on spinal cord and cortical excitability in sci participants. it is expected that this project will successfully establish a new neuromodulation technology to enhance cortical, corticospinal and spinal circuit excitability as well as to improve the outcome of lower-limb function and quality of life in persons with sci. therefore, this project can not only publish scientific papers, but also can enhance the neuroplasticity and improve function in persons with sci.

Eligibility criteria:
inclusion criteria: 1. age 20 to 65 years incomplete sci (american spinal injury association impairment scale (asia) b to d) 2. lesion area above the tenth thoracic vertebra (t10) 3. injury time more than one year 4. without range of motion (rom) limitation 5. medical condition stable exclusion criteria: 1. having pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy. 2. having seizure history 3. having other neurological, mental, medical problems affect this study

Keywords: spinal cord injuries trans-cranial magnetic stimulation trans-spinal direct current stimulation
a study to help people quit smoking.

Conditions: Nicotine Dependence

Summary: you are invited to participate in a research study at the va connecticut healthcare system (west haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. you have been invited to participate because you currently smoke cigarettes, and want to quit smoking. if you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. to determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.

we propose a double-blind, placebo-controlled, outpatient study with a between-groups design. seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: gal (8 or 16 mg/day) or placebo. the dose of gal will be gradually increased to the target doses over a 2-week period (table 2). during week 3, following overnight abstinence from smoking, participants will present for a laboratory test session in which they will have the option of cigarette self-administration. after this test session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. smokers will establish a quit date at the beginning of this treatment phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. additionally, at the beginning of week 3, participants will be given a pda that will administer ema assessments. the study medication will be tapered after the end of week 4 of the treatment phase. participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.

Eligibility criteria:
inclusion criteria: * female and male smokers, aged 18 to 55 years; * history of smoking daily for the past 12 months, at least 10 cigarettes daily; * in good health as verified by medical history, screening examination, and screening laboratory tests; * for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods. exclusion criteria: * history of gal allergy; * requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months); * serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders; * abuse of alcohol or any other illicit or prescription drugs; * use of any other tobacco products, including smokeless tobacco and nicotine products; and * inability to fulfill all scheduled visits and examination procedures throughout the study period.

Keywords: addiction smoking tobacco cigarettes
ultrasound detection and characterization of subclinical hypertrophy in diabetes

Conditions: Diabetes; Lipohypertrophy

Summary: this is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as detected with ultrasound and its impact on glycemic variability.

lipohypertrophy is a well documented phenomenon in patients with diabetes in which hypertrophy and differentiation of adipocytes occurs in the dermal reticular layer at the sites of subcutaneous insulin injection. currently, lipohypertrophy is assessed by palpating insulin injection sites. the detection on early, non palpable (subclinical) lipohypertrophy remains difficult in the clinical setting. recent studies have identified distinct ultrasonographic features of hyperechogenicity in areas of adipose tissue consistent with clinical evidence of lipohypertrophy at insulin injection sites, and have detected changes int he thickness of subcutaneous tissue where not clinically evident in population of patients with type 1 diabetes. lipohypertrophy can adversely affect glycemic control. injecting into lipohypertrophic areas leads to poor absorption and the need for increasing doses of insulin. in this study study participants will undergo an assessment for lipohypertrophy during a scheduled visit at the vgh diabetes centre. a diabetes nurse will assess lipohypertrophy by palpation according to the fit protocol. a second diabetes nurse who was not present at the palpation will assess insulin injection sites for lipohypertrophy by ultrasound using a linear probe.

Eligibility criteria:
inclusion criteria: * 19 years of age or older * type 1 or type 2 diabetes * using insulin to manage diabetes for at least 2 years exclusion criteria: * using insulin pumps, insulin secretagogues, glucagon-like peptide-1 (glp-1) agonists to manage diabetes * use of immunosuppressant agents * women who are pregnant

Keywords: diabetes lipohypertrophy ultrasound
national database of the virtual institute of cerebrovascular diseases

Conditions: Cerebrovascular Disease

Summary: the primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables. each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.


Eligibility criteria:
inclusion criteria: * diagnosis of cerebrovascular pathology defined according to the ninds special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the international classification of diseases, 9th revision (icd-9): icd-9 430-438; * informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors. exclusion criteria: * the patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study; * onset of cerebrovascular disease before january 1, 2016.
acellular dermal matrix in tissue expander breast reconstruction: a prospective, randomized, clinical trial comparing surgimend prs and alloderm rtu

Conditions: Breast Cancer; Mastectomy

Summary: the purpose of this study is to assess the relative performance and complication rates between the alloderm rtu and surgimend prs products as well as the relative economics of these two treatment options.

in recent years, acellular dermal matrix (adm) products have increasingly been utilized in breast reconstruction in order to protect the implant from exposure under a thin mastectomy skin flap while also allowing better control of the inframammary fold and, therefore, a better cosmetic result. in current clinical practice, cost is a factor in considering procedures and adjunct products. alloderm rtu and surgimend prs are dissimilar in cost, with alloderm rtu more costly by 30-50%, and it is unclear if they are similar in efficacy. this study will be a prospective, randomized-to-test article (adm), controlled, blinded-to-aesthetic/biopsy specimen evaluator trial. it will provide a way to assess the relative performance and complication rates between the alloderm rtu and surgimend prs product as well as the relative economics of these two treatment options. study subjects will only be randomized to one of two surgical mesh products. patient information including age, bmi, smoking history, tumor size and location, preoperative bra cup size, mastectomy specimen weight, mastectomy method, plastic surgeon, mastectomy surgeon, quality of skin, tissue expander type and maximal volume, intra-operative fill volume, gel/saline implant type and size, chemotherapy, and radiation therapy will be summarized.

Eligibility criteria:
inclusion criteria: 1. subject's with ability to provide informed consent. 2. subjects greater than 18 years old 3. subjects to undergo an immediate tissue expander reconstruction following mastectomy; and 4. subjects who are, in the opinion of the investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits. exclusion criteria: 1. subjects less than 18 years of age 2. subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of adm product 3. pregnancy 4. bovine allergy

Keywords: breast cancer mastectomy immediate reconstruction
brain vital signs m-score: point-of-care monitoring for motor recovery after stroke

Conditions: Stroke

Summary: the purpose of this study is to investigate brain signals relating to motor function, using electroencephalography (eeg) technology. the aims of the study can be separated into 3 specific study objectives: 1. record eeg data from control participants and individuals with stroke during basic motor tasks and build a database of eeg signals to enable analysis of motor control. 2. apply signal processing algorithms to extract eeg features related to motor control. 3. develop a framework/the motor score (m-score) that uses the eeg signals, in combination with machine learning approaches, to quantify motor control ability.


Eligibility criteria:
inclusion criteria: * age requirements: * younger adult control participants (19-40 years old) * older adult control participants (41-80 years old) * individuals with stroke (19-80 years old) * capacity to follow single stage commands * stroke specific inclusion criteria * upper-limb disability as a result of a stroke (\>1 month ago) exclusion criteria: * cognitive difficulties that undermine ability to give informed consent (montreal cognitive assessment (moca) score below 23). * severe paralysis such that the participant cannot perform simple movements (such as finger tapping, clicking a mouse, etc.) * history of head trauma, a major psychiatric diagnosis, neurodegenerative disorder or substance abuse
efficacy and safety of hrs-7535 in for heart failure with preserved ejection fraction and obesity

Conditions: Adults' Obesity With Heart Failure With Preserved Ejection Fraction

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel design phase ii clinical trial, including a screening period of up to 2 weeks, a 40-weeks' treatment period, and a 1-week safety follow-up visit period.


Eligibility criteria:
inclusion criteria: 1. male or female, on the day of signing the informed consent form, aged between 18 and 80 years old; 2. diagnosed with chronic heart failure for at least 3 months before screening, and diagnosed with heart failure with preserved ejection fraction according to the national heart failure guidelines 2023 during the screening period; 3. screening period and day 1 randomization before new york heart association (nyha) functional classification ii-iv; 4. during the screening period and on the first day before randomization, the body mass index (bmi) was ≥ 28 kg/m2; 5. self reported having controlled diet and exercise for 3 months or more before screening, and having a weight change of no more than 5kg within the first 3 months of screening and randomization; 6. during the screening period and on the first day of randomization, the total clinical score (kccq-css) of the kansas city cardiomyopathy questionnaire should be ≤ 80 points; 7. prior to screening, the stable dose of medication for underlying diseases (excluding oral diuretics) should be ≥ 4 weeks; 8. capable and willing to comply with the protocol requirements, fully understand the trial content, process, and possible adverse reactions, capable and willing to comply with the protocol requirements to complete this study (such as subject log recording), able to fully understand and complete the kansas city cardiomyopathy questionnaire (kccq) questionnaire and patient health questionnaire-9 (phq-9) scoring. exclusion criteria: 1. individuals with special clinical characteristics or disease history during screening, such as myocardial infarction, acute decompensated heart failure, hospitalization or emergency treatment due to heart failure (excluding hospitalization as specified in the trial protocol), unstable angina, stroke, or transient ischemic attack within the 30 days prior to screening or during the screening period; 2. during the screening period or on the first day of randomization, there may be laboratory tests with clinical significance, such as a 12 lead electrocardiogram indicating persistent sinus tachycardia; 3. those who have used certain drugs or treatments before screening, such as those that may cause significant weight gain or loss within the past 3 months; 4. based on the researcher's judgment, there are any situations that may affect the safety of the subjects or interfere with the evaluation of the trial results (such as medical, psychological, social, or geographical factors).